2. Stability and safety study of liquid-suspension bacillus clausii spore probiotics (livespo clausy)
Main Article Content
Abstract
Bacillus clausii has been used as probiotic bacteria in dietary supplements because of its prominent probiotic activities including its multi-antibiotic resistance, digestive enzyme production, vitamin synthesis, and immunomodulatory effects. In this study, heat and acid-stability, acute and sub-acute toxicity were conducted to evaluate the stability and safety of liquid-suspension probiotics (LiveSpo® Clausy, LiveSpo Pharma) containing ≥ 2 billion spores/5 mL of Bacillus clausii ANA39 strain. The result showed that the B. clausii ANA39 spores were heat- and acid pH-stable with the remaining survival rate of 60% and 40% at treatment conditions of 80oC and pH 2.0 for 20 min, respectively. Acute toxicity data in mice indicated LD50 was not detectable, even at extremely high dosage of 2.4 x 1010 CFU/kg, indicating LiveSpo® Clausy was in unclassified category. The sub-acute toxicity results showed that the rabbits administrated with B. clausii ANA39 at the dosages of 0.93 mL/kg rabbit/day (equivalent to 0.37 x 109 CFU ANA39 spores/kg rabbit/day) and 2.80 mL/kg rabbit/day (equivalent to 1.12 x 109 CFU of B. clausii ANA39 spores/kg rabbit/day) were healthy and steadily gained weight without any abnormal physiology and anatomy. Thus, LiveSpo® Clausy is resistant to high temperatures and low pH acids, stable for at least 24 months at room temperature, and safe for use as food supplements.
Article Details
Keywords
acid stability, acute toxicity, Bacillus clausii, heat stability, spore, sub-acute toxicity.
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